Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

Phase 1

Completed

• Conditions: Diabetic Retinopathy; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases
• Interventions: Drug: Ranibizumab; Procedure: Laser therapy

• Registration Number: NCT01746563
• Lead Sponsor: University of Sao Paulo

Brief Summary

To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

Detailed Description

Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).

Objectives:

Primary objective:

The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).

Secondary objectives:

To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments.

To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments.

Strategic goal:

The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-07
• Last Update Submitted: 2012-12-07
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Naive Proliferative diabetic retinopathy eyes.
• Best Corrected-Visual Acuity at baseline > 20/320 in the study eye
• Patients with and without diabetic macular edema
• Type II diabetic subjects as defined by the World Health Organization aged ≥ 18 years.
• Women must be using effective contraception
• Ability to provide written informed consent.
• Indication of panretinal photocoagulation in both eyes

Exclusion Criteria

• Vitreous hemorrhage or pre-retinal hemorrhage
• Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months
• Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
• Cataract
• Any intraocular surgery within 6 months before trial enrollment
• Previous vitrectomy.
• Any of the following underlying systemic diseases:
• History or evidence of severe cardiac disease or previous thrombus-embolic event

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Laser therapy	Ranibizumab 0,05 mg intravitreal injection
Laser Therapy	Laser therapy	Laser Therapy alone
Ranibizumab	Ranibizumab	Ranibizumab 0,05 mg intravitreal injection

Primary Outcome Measures

Name	Time	Method
Macular Evaluation	6 Months	Changes between visual acuity from baseline to month 6.

Secondary Outcome Measures

Name	Time	Method
Structural Macular Evaluation	06 months	Change on retinal thickness between baseline and Month 6

Trial Locations

Locations (1)

Universidade of Sao Paulo; 🇧🇷 Sao Paulo, Brazil